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Orion Genomics (St. Louis) said that it has identified and validated a suite of new breast cancer biomarkers, the most promising of which will be incorporated into the company’s diagnostic assays for the early detection of breast cancer and the detection of breast cancer recurrence.

The results of Orion’s genome-wide, DNA methylation profiling were presented at the recent 29th annual San Antonio Breast Cancer Symposium in Texas.

Using genome-wide microarray technology, the company was able to “quickly identify” a suite of novel biomarkers in a panel consisting of normal and cancerous breast tissues, it said.

In a second independent biomarker validation panel of more than 200 normal and cancerous breast tissues, over 50 biomarkers demonstrated significant diagnostic potential, the most promising of which presented 90% sensitivity and 96% specificity.

“Utilizing MethylScope, our genome-wide DNA methylation profiling technology, we were able to quickly identify a suite of promising breast cancer biomarkers that show significantly high sensitivity and specificity and represent the most comprehensive and clinically accurate breast cancer epigenetic biomarkers discovered to date,” said Jorge Leon, PhD, Orion’s acting chief scientific officer. “We are now validating our most promising biomarkers in blood serum from cancer-free and breast cancer patients.”

According to the American Cancer Society (Atlanta), an estimated 211,000 new cases of invasive breast cancer are expected in the U.S. in 2006 alone, where about 40,000 patients are expected to die of their disease.

Early detection and treatment when the tumor is still small remains a key factor in survival; however, early stage breast cancer typically produces no noticeable symptoms, making early detection through conventional methods challenging.

“Identifying cancer earlier in the disease progression timeline will significantly improve treatment outcomes and patient survival, especially in breast cancer,” said Nathan Lakey, president/CEO of Orion Genomics. “Our identification and validation of sensitive and specific biomarkers for the detection of breast cancer will form the foundation of our breast cancer diagnostic assays. These assays will provide a diagnostic screening test, from blood or other easily collected samples, of a large population for the early or recurrent signs of breast cancer.”

In other news from the symposium, researchers from the Mayo Clinic Cancer Center (Jacksonville, Florida) said that while many men have breast symptoms, including enlarged or painful breast tissue, the majority do not need a mammogram.

Mammograms are used to check for the presence of breast cancers, which are very rare in males.

Their study suggested that physicians should reconsider ordering mammograms for men, who are most often diagnosed with non-cancerous gynecomastia, a common condition which includes breast swelling, a tender mass or painful breast tissue.

“Mammography is being performed with increasing frequency in men with breast symptoms, but we found that breast cancer in men can be felt as a firm, discrete mass on a physical exam, or seen as changes in the skin or nipple,” says the study’s lead author, Stephanie Hines, MD, of Mayo’s Multidisciplinary Breast Clinic and Breast Cancer Program in Jacksonville, Florida. “Male breast cancer is exceedingly rare — fewer than 2,000 men in the United States are diagnosed with the condition annually,” she said.

Conversely, gynecomastia is found in 60% to 90% of male infants, in 30% to 60% of boys going through puberty, and in 24% to 65% of adult men, according to Hines. The condition has a number of causes, including hormonal imbalance, use of certain medications, organ failure, and alcohol use. Gynecomastia can be detected in a physical exam and can often be diagnosed solely based on the clinical evaluation.

“So, in the vast majority of cases, a mammogram is not necessary for confirming a diagnosis of gynecomastia. Breast cancer is rare and most often easily detected on physical examination,” said Hines.

In this study, researchers retrospectively reviewed the records of all men who had a mammogram at Mayo Clinic Jacksonville from 2001 to 2004. A total of 212 mammograms were performed on 198 patients. The researchers said only three men were diagnosed with breast cancer, and of these, all three men had an obvious mass in the breast that could be felt on physical exam, or had changes, such as retracted skin or nipple, that are associated with tumor development. In one of the three men, the mammogram showed a mass initially diagnosed as benign that was later discovered to be cancerous.

However, the researchers found that 83% of the men who had mammograms and had been diagnosed with gynecomastia were taking a medication, or had a medical condition, that could predispose them to developing breast swelling.

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